Drugs used for cancer chemotherapy tend to be highly cytotoxic and genotoxic, with well-documented carcinogenic, mutagenic, and teratogenic effects. Long-term, occupational exposure to these highly toxic drugs presents serious health risks to the healthcare personnel who routinely prepare and administer chemotherapy, such as cancers, infertility, miscarriages, birth defects, spontaneous abortions, and congenital malformations. Leakage in the form of liquid, particulate, or vapor can occur during any of several steps in the process of compounding the drug and administering it to the patient, and several studies suggest the potential for workplace contamination is widespread. Closed system transfer devices (CSTDs) were originally developed to mitigate these risks, but the devices that are currently available in the marketplace suffer from a number of shortcomings, including leakage, needle sticks, inefficiencies, difficulty of use, and repetitive stress injuries. The objective of this Phase I SBIR proposal is to test the feasibility of a new, innovative disposable CSTD design that has the potential to provide superior drug containment capabilities. Feasibility will be determined by pursuing two specific aims. In Aim 1, this unique concept will be refined through a series of design iterations linked to fabrication and testing of rapid prototypes, culminating in production of a proof-of concept, working prototype that can be rigorously tested to establish its performance characteristics in Aim 2. Performance of the working prototype will be validated under real-life, process simulation conditions to determine whether it can contain leakage and maintain sterility during operation under the most challenging and stressful conditions encountered during drug compounding. Containment will be measured by sensitive visual and analytical methods, and sterility will be determined using United States Pharmacopeia standards for media fill. Successful completion of the phase I design and development studies will establish the groundwork for this novel, disposable CSTD as the cornerstone of a disruptive technology that will undergo further development in Phase II. As the population ages and the number of cancer patients grows, the demand for chemotherapy drug compounding is expected to increase, especially the preparation of tailored therapies for point-of-care use. The unique approach described in this proposal will benefit healthcare staff and patients alike by reducing the risks of occupational exposure and improving the accuracy of patient medications, while simultaneously increasing efficiencies and reducing costs. We anticipate our innovative CSTD will introduce unprecedented safety and efficiency improvements, strategically positioning J&J to capitalize on a rapidly growing $500 million market while reducing the risks associated with compounding and administering hazardous chemotherapy drugs. PUBLIC HEALTH RELEVANCE: Millions of healthcare workers are at risk of exposure to hazardous drugs, such as chemotherapeutics used to treat cancer patients, during drug preparation and administration. Closed system transfer devices (CSTDs) were originally developed with the goal of protecting workers from the hazards of exposure to highly toxic drugs, but current devices have several shortcomings. This proposal describes an innovative design and approach for a new type of disposable CSTD that will provide better protection for healthcare workers and cancer patients alike, achieved by limiting the release of these hazardous drugs into the work environment.